Prospective Natural History Study of Smoking, Immune Cell Profiles, Epigenetics and COVID-19

NCT04403386 | Completed

• 2 other identifiers: 20010820-E-0108
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Early evidence in the COVID-19 pandemic suggests that smokers are at a higher risk of having severe effects or dying from the disease. Smoking causes changes in immune cells. Researchers think this may be the reason why smokers are more likely to have severe effects from COVID-19. Researchers want to better understand the interaction between smoking history, the immune system, and COVID-19. Objective: To better understand how COVID-19 affects smokers and non-smokers immune systems before and after being infected with the virus. Eligibility: Healthy people ages 30-55 who are a smokers or non-smokers who may potentially contract COVID-19 Design: Participants will be screened over the phone. They will answer questions about their demographics, medical history, medications, and smoking status. Participants will have up to 6 monthly visits. At the first visit, participants will have blood tests. Blood will be drawn through a needle in an arm vein. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. Their height and weight will be taken. They will complete questionnaires about their medical history and smoking status. Participants will then have monthly visits. They will have blood draws to test for COVID-19 antibodies. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. These visits will occur 4 times or until they have a positive antibody result. Participants will have a final visit. They will have blood tests. They will provide a saliva sample in a container and have a cheek swab. The participant will also have a nasal swab to see if they currently have COVID-19. If at any time participants test positive for a COVID-19, they will be rescheduled 14 days or more after they no longer have symptoms....

Conditions

COVID-19

Keywords

Smoke Exposure; CyTOF Assay; Non-Smoker; Antibody Test; Natural History

Outcome Measures

Primary Outcomes (1)

• Levels of senescent CD16+CD8+ T cells prior to COVID-19 disease and time to COVID-19 disease morbidity (antibody positvity).

  The presence of elevated senescent CD16+CD8+ T cells is an indication of immune dysfunction and could be a susceptibility factor.

  At pre and post COVID 19 infection

Study Arms (2)

non-smokers

Participants who have never smoked or do not currently reside with a smoker

Smokers

Participants who currently smokes and has smoked for at least 5 years

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy smokers and nonsmokers age 30-55 years

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male and females
• Age 30 to 55 years
• Able to travel to study visits at the NIEHS CRU for required study visits
• Body mass index (BMI) range between 18 and 35 at enrollment
• Must self-identify as a current smoker (cigarettes and/or use of an e-cigarette/vaping device), have smoked for 5 years or longer or identify as a non-smoker, having never used of any other forms of tobacco, nicotine, or smoked marijuana and not currently residing with a smoker (There may be circumstances where the investigator will still want to include the par icipant (for example when a participant has smoked a couple times in the past and the Investigator feels it has been long enough that they can be included as a nonsmoker or they smoked for over 5 years and quit for a day so they can still be included as a smoker). However, these are expected to be rare and will need to be assessed on a case by case basis by the Investigator to maintain scientific integrity)

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• History of confirmed COVID-19 infection
• Current diagnosis of cancer or prior history of cancer, with the exception of nonmelanoma skin cancer because nonmelanoma skin cancers are not relate to tobacco smoking and are very common (approximately 20% of US population will develop these). Treatments are generally topical creams or minor surgery with a very high cure rate. If these treatments occurred in the past, they are unlikely to impact the outcomes we are measuring in our pre and post disease study design
• Bleeding disorder or any reason that a blood sample cannot be provided
• Current pregnancy or lactation, by participant verbal confirmation.
• Any condition that, in the investigator's opinion, places the participant at undue risk for complications associated with required study procedures

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

NIEHS Clinical Research Unit (CRU)

Research Triangle Park, North Carolina, 27709, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stavros Garantziotis, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2020
• First Posted: May 27, 2020
• Study Start: June 1, 2020
• Primary Completion: September 6, 2022
• Study Completion: February 24, 2023
• Last Updated: March 6, 2026

Record last verified: 2026-03-04

Locations

US (1)